Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06264518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-09', 'size': 79118, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-09T11:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who decide to enroll in a traumatic brain injury clinical trial', 'timeFrame': '3 months'}, {'measure': 'Rate of patients who remain in traumatic brain injury clinical trial to trial completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic Brain Injury'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '35672125', 'type': 'BACKGROUND', 'citation': 'Giner J, Mesa Galan L, Yus Teruel S, Guallar Espallargas MC, Perez Lopez C, Isla Guerrero A, Roda Frade J. Traumatic brain injury in the new millennium: new population and new management. Neurologia (Engl Ed). 2022 Jun;37(5):383-389. doi: 10.1016/j.nrleng.2019.03.024. Epub 2021 Apr 29.'}, {'pmid': '35693562', 'type': 'BACKGROUND', 'citation': 'Hagos A, Tedla F, Tadele A, Zewdie A. Pattern and Outcome of Traumatic Brain Injury, Addis Ababa, Ethiopia: A Cross-sectional Hospital-based Study. Ethiop J Health Sci. 2022 Mar;32(2):343-350. doi: 10.4314/ejhs.v32i2.15.'}, {'pmid': '37464844', 'type': 'BACKGROUND', 'citation': 'Shrestha A, Paudel N, Adhikari G, Shrestha S, Lamichhane S, Subedi S, Jaishwal N. Traumatic Brain Injury among Patients Admitted in Neurosurgical Unit in a Tertiary Care Centre: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2023 Jun 1;61(262):514-518. doi: 10.31729/jnma.8197.'}]}, 'descriptionModule': {'briefSummary': "Clinical study participation has historically been heavily biased toward specific demographics.\n\nSeveral people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.\n\nPeople with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Quantity of participants in traumatic brain injury study who sustain participation until study completion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been diagnosed with traumatic brain injury\n* Patient has self-identified as planning to enroll in an observational clinical trial\n* Patient is a minimum of 18 years or older\n\nExclusion Criteria:\n\n* Pregnant or nursing patients\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form'}, 'identificationModule': {'nctId': 'NCT06264518', 'briefTitle': 'An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Exploration of Traumatic Brain Injury Clinical Trials: Unveiling Patient Participation Patterns', 'orgStudyIdInfo': {'id': '56168915'}}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'https://www.withpower.com/contact-us@withpower.com', 'phone': '415-900-4227'}], 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '4159004227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}